NCT02900352

Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.

Detailed description

This is a 16-week randomized, double blind, placebo-controlled trial designed to determine the effectiveness of zonisamide treatment for reducing heavy drinking and overall drinking in 160 treatment-seeking, regularly heavy drinking, alcohol-dependent civilians who want to quit drinking or reduce consumption to non-hazardous levels. The investigators will use state-of-the-art methodology and outcome assessments, including medical management (MM) therapy (a minimal behavioral intervention aimed at reinforcing treatment goals and adherence to medication), which is simple and easily implemented in primary care settings. The use of MM in the study will increase the generalizability of results, allowing a more accurate assessment of zonisamide's effectiveness than if a more intensive behavioral intervention were to be used. To demonstrate zonisamide's effectiveness in a representative civilian sample, the investigators will include civilians with co-morbid mood and anxiety disorders.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Zonisamide	Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
DRUG	Placebo	Placebo

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-04-22
• Completion: 2021-04-22
• First posted: 2016-09-14
• Last updated: 2022-10-13
• Results posted: 2022-10-13

Locations

4 sites across 1 country: United States